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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05115617
Other study ID # CTO 3612
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 3, 2021
Est. completion date August 2024

Study information

Verified date March 2024
Source Ottawa Hospital Research Institute
Contact Stephanie Boyd, MBA
Phone 613-737-8899
Email sboyd@ohri.ca
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The PLAN-V Study is an Ontario-based prospective, longitudinal study that will consist of extensive biosampling and detailed data collection from pregnant women/individuals, who have received the COVID-19 vaccine during their pregnancy, and their infants across the antenatal, delivery and postpartum periods.


Description:

There is a pressing need for research to answer critical questions about the role of maternal vaccination for protection of the mother-infant dyad, to inform public health recommendations and to support evidence-based decision-making by Canadian families and their care providers. The investigators' goal is to generate rapid, reliable evidence specific to the immunogenicity and safety of COVID-19 vaccines in the pregnant population. The specific PLAN-V Study objectives are: 1. To evaluate immunogenicity of COVID-19 vaccines in pregnant women/individuals and the fetal/newborn immune response to maternal vaccination. 2. To evaluate safety of COVID-19 vaccination in pregnant women/individuals based on obstetrical, fetal and newborn health outcomes. 3. To compare immune responses to COVID-19 vaccination and natural COVID-19 disease among pregnant women/individuals and their infants exposed in utero 4. To compare the immune responses to COVID-19 vaccination between pregnant and non-pregnant women/individuals. PLAN-V is an Ontario-based prospective, longitudinal study that will consist of extensive biosampling and detailed data collection from pregnant women/individuals and their infants across the prenatal, delivery and postpartum periods. With this approach, detailed participant profiles will be generated that will enable us to explore vaccine reactogenicity; vaccine-associated adverse events; frequency of obstetrical and fetal/newborn outcomes; and measures of infant health and well-being. The study will build on existing resources and expertise available through the COVID-19 Ontario Pregnancy Event (COPE) Network to establish a prospective, longitudinal cohort study of pregnant women/individuals, and their infants. The PLAN-V Study will consist of pregnant women/individuals who are planning to receive a COVID-19 vaccine(s) at any stage in pregnancy.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date August 2024
Est. primary completion date August 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria: - Women/Individuals = 16 years of age who are =7 0/7 weeks' gestation on the day of enrollment - Capacity to provide informed consent and to comprehend and comply with the study requirements - Planning to deliver at a participating site hospital - Planning to receive or have previously received one-dose of a Health Canada approved COVID-19 vaccine (any product, any number of doses) during the current pregnancy Exclusion Criteria: - Cases with known major fetal concerns - Women/Individuals who are fully vaccinated against COVID-19 - Women/Individuals who are pregnant due to surrogacy, or planning to give their child up for adoption - Women/Individuals with a non-viable pregnancy (e.g., ectopic)

Study Design


Locations

Country Name City State
Canada Hamilton Health Sciences Corporation Hamilton Ontario
Canada Kingston Health Sciences Centre Kingston Ontario
Canada London Health Sciences London Ontario
Canada The Ottawa Hospital - Civic Campus Ottawa Ontario
Canada The Ottawa Hospital - General Ottawa Ontario
Canada St. Michael's Hospital Toronto Ontario
Canada Sunnybrook Health Sciences Centre Toronto Ontario

Sponsors (4)

Lead Sponsor Collaborator
Ottawa Hospital Research Institute Canadian Institutes of Health Research (CIHR), Children's Hospital of Eastern Ontario Research Institute, University of Ottawa

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Antibody titres in biological samples Immunogenicity of COVID-19 Vaccines: Seroconversion rates in vaccinated mothers, SARS-CoV-2 antibody titres and their persistence in mothers after vaccination in pregnancy, transfer of antibodies to breastmilk/chestmilk, transfer and persistence of SARS-CoV-2 antibodies to the neonate/infant over the study period. 1-month post COVID-19 vaccine
Primary Antibody titres in biological samples Immunogenicity of COVID-19 Vaccines: Seroconversion rates in vaccinated mothers, SARS-CoV-2 antibody titres and their persistence in mothers after vaccination in pregnancy, transfer of antibodies to breastmilk/chestmilk, transfer and persistence of SARS-CoV-2 antibodies to the neonate/infant over the study period. 3-month, and 6-month post COVID-19 vaccine
Primary Antibody titres in biological samples Immunogenicity of COVID-19 Vaccines: Seroconversion rates in vaccinated mothers, SARS-CoV-2 antibody titres and their persistence in mothers after vaccination in pregnancy, transfer of antibodies to breastmilk/chestmilk, transfer and persistence of SARS-CoV-2 antibodies to the neonate/infant over the study period. 6-month post COVID-19 vaccine
Primary Antibody titres in biological samples Immunogenicity of COVID-19 Vaccines: Seroconversion rates in vaccinated mothers, SARS-CoV-2 antibody titres and their persistence in mothers after vaccination in pregnancy, transfer of antibodies to breastmilk/chestmilk, transfer and persistence of SARS-CoV-2 antibodies to the neonate/infant over the study period. At delivery
Primary Antibody titres in biological samples of participants who received COVID-19 vaccine and who had natural COVID-19 disease. Comparing immune responses to COVID-19 vaccination in pregnant and non-pregnant women/individuals 6-months post-COVID-19 vaccine
Primary Antibody titres in biological samples of participants who received COVID-19 vaccine and who had natural COVID-19 disease. Comparing immune responses to COVID-19 vaccination in pregnant and non-pregnant women/individuals 3-month post-COVID-19 vaccine
Primary Antibody titres in biological samples of participants who received COVID-19 vaccine and who had natural COVID-19 disease. Comparing immune responses to COVID-19 vaccination in pregnant and non-pregnant women/individuals 1-month post-COVID-19 vaccine
Primary Antibody titres in biological samples of pregnant and non-pregnant populations Comparing infection-acquired and vaccine-acquired immunity against COVID-19 in mothers and newborns During delivery admission
Secondary Maternal death Maternal death during delivery admission through study completion, an average of 9 months
Secondary Maternal - Non-delivery hospitalization Any hospitalization not associated with the delivery of infant. through study completion, an average of 9 months)
Secondary Any infection Maternal diagnosis of any infection during pregnancy through study completion, an average of 9 months
Secondary Pre-term labour The onset of labour prior to 37 weeks gestation through study completion, an average of 9 months
Secondary Hypertensive disorders of pregnancy The diagnosis of a hypertensive disorder of pregnancy through study completion, an average of 9 months
Secondary Placental abruption The diagnosis of placental abruption during pregnancy through study completion, an average of 9 months
Secondary Postpartum hemorrhage The diagnosis of postpartum hemorrhage Post-delivery, during the delivery admission
Secondary Preterm birth Infant born prior to 37 weeks gestation through study completion, an average of 9 months
Secondary Fetal loss or stillbirth Fetal loss or stillbirth throughout the pregnancy through study completion, an average of 9 months
Secondary Small for gestational age <10th percentile for gestational age and sex- specific birth weight During the pregnancy, through study completion, an average of 9 months
Secondary Term low birthweight <2500g At delivery
Secondary Low 5 min Apgar Score Score <5 at 5 minutes At delivery
Secondary Low cord blood pH cord blood pH<7.0 At delivery
Secondary admission to neonatal ICU for >12 hours Infant admission to the neonatal ICU for >12 hours During delivery admission
Secondary composite neonatal adverse outcome indicator [NAOI] A composite indicator which includes various neonatal adverse outcomes At delivery
Secondary Frequency of infection Number of infections, including but not limited to: influenza, pneumonia, sepsis, acute respiratory infections, gastrointestinal Postpartum, through study completion, an average of 9 months
Secondary Re-hospitalization rates Number of re-hospitalizations and emergency visits Postpartum, through study completion, an average of 9 months
Secondary Composite indicator for complex chronic conditions Composite indicator includes: neurologic and neuromuscular; cardiovascular; respiratory; renal and urologic; gastrointestinal; hematologic or immunologic; metabolic; other congenital or genetic defect; and malignancy Postpartum, through study completion, an average of 9 months
Secondary Infant death Infant death Postpartum, through study completion, an average of 9 months
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